Orthodontic AlignersAlignerNCT06330571

The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial.

A study testing Molar distalization by aligners with attachment in people with Orthodontic Aligners, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization. Read more about this study

Who is it for?: Ages 15 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Orthodontic Aligners
What is being tested?: Molar distalization by aligners with attachment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2023to 15 Oct 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Age more than15 years.
Gender; male or female.
Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
Mild crowding in the upper arch (≤ 4 mm).
Absence or previous extraction of the upper third molars.
Good compliance during the treatment

Who cannot join

Transversal dental or skeletal discrepancies.
Extraction treatment (except for the third molar).
Periodontal disease. .
Prosthodontics rehabilitation of the maxillary molars.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ainshams university
Cairo

Other trials in Egypt

About this study

Official title: The Accuracy of Clear Aligners in Maxillary Molar Distalization With and Without Attachments: A Randomized Clinical Trial.

The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.

Conditions: Orthodontic Aligners
Being tested: Molar distalization by aligners with attachment
Keywords: Orthodontic, aligner, molar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Molar distalization by aligners with attachmentDevice
1. Plaster dental models will be poured from the rubber base impression.
2. Digital dental models will be created through scanning of plaster dental models.
3. Planning of the aligners will be done on 3 shape clear aligner.
4. Aligners will be fabricated on 3d printed models.
5. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
6. Patient will receive the following aligner after 2 weeks.
7. Follow up visits every 4weeks until 6 months.

Study groups in NCT06330571
Study group	Role	What they receive
Molar distalization by aligners without attachment	Active comparator	Not described Receives: Device: Molar distalization by aligners with attachment
Molar distalization by aligners with attachments	Experimental	Not described Receives: Device: Molar distalization by aligners with attachment

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficiency of aligners in molar distalization
T2(3shape)-T1(actual) <mm>
Measured: 6 months

Secondary outcomes (2)

Amount of anchorage loss
Linear ( mm)
Measured: 6 months
Amount of molar tipping
Angular
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202315 Oct 2025

First posted26 Mar 2024
Study start1 Jan 2023
Primary completion1 Oct 2025
Study completion15 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Orthodontic AlignersStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06330571
Sponsor's protocol ID: Aligners in distalization
Acronym: Aligner
Status last verified: Jul 2022
First submitted: 17 Mar 2022
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Active, not recruitingObservational study
Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
Malocclusion, Periodontal Diseases
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
Not yet recruitingPhase 1/2
Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners
Orthodontic Tooth Movement

All Orthodontic Aligners trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Accuracy of Clear Aligners in Maxillary Molar Distalization With and Without Attachments: A Randomized Clinical Trial.
ClinicalTrials.gov ID: NCT06330571
Acronym / sponsor ID: Aligner / Aligners in distalization
Conditions: Orthodontic Aligners
Keywords: Orthodontic, aligner, molar
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 1 Jan 2023 (actual)
Primary completion: 1 Oct 2025 (actual)
Study completion: 15 Oct 2025 (actual)
First posted: 26 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Molar distalization by aligners without attachment	Active comparator	Device: Molar distalization by aligners with attachment
Molar distalization by aligners with attachments	Experimental	Device: Molar distalization by aligners with attachment

Who may qualify

Ages: 15 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Age more than15 years.
Gender; male or female.
Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
Mild crowding in the upper arch (≤ 4 mm).
Absence or previous extraction of the upper third molars.

Key exclusion criteria (4 listed)

Transversal dental or skeletal discrepancies.
Extraction treatment (except for the third molar).
Periodontal disease. .
Prosthodontics rehabilitation of the maxillary molars.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Molar distalization by aligners with attachment1. Plaster dental models will be poured from the rubber base impression. 2. Digital dental models will be created through scanning of plaster dental models. 3. Planning of the aligners will be done on 3 shape clear aligner. 4. Aligners will be fabricated on 3d printed models. 5. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks. 6. Patient will receive the following aligner after 2 weeks. 7. Follow up visits every 4weeks until 6 months.	Device	Molar distalization by aligners with attachments, Molar distalization by aligners without attachment

Primary outcome

Efficiency of aligners in molar distalization
Time frame: 6 months
T2(3shape)-T1(actual) <mm>

2 secondary outcomes

Amount of anchorage loss
Time frame: 6 months
Amount of molar tipping
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Orthodontic Aligners

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Active, not recruitingObservational study
Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
Malocclusion, Periodontal Diseases
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
Not yet recruitingPhase 1/2
Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners
Orthodontic Tooth Movement

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Noha E Sabet, Prof study chair

Ain Shams University

Marwa s Abdelatef, Phd study director

Ain Shams University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Molar distalization by aligners with attachment in people with Orthodontic Aligners, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficiency of aligners in molar distalization (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06330571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.